1. Field of the Invention
The present invention relates to surgical procedures, and more particularly to a method and apparatus for the removal of liquid wastes generated during and after the course of said procedures.
2. Description of Related Art
The present invention relates to devices and methods for material handling, monitoring, and documentation for use in the medical field and in one embodiment a method and apparatus for handling, collecting, measuring and/or disposing of fluids, including gases and liquids, that are associated with surgical and other medical procedures. The use of the method and apparatus of the present invention will reduce the number of potential exposure events of healthcare workers to infectious and possibly toxic waste associated with surgery, clinical procedures, post-operative, and intensive care settings.
There has long been recognition of the collective potential for ill effects to healthcare workers from exposure to biohazardous materials in a variety of healthcare settings. Federal and state regulatory agencies have issued mandatory guidelines for the control of such materials, in particular bloodborne pathogens.
The presence of biohazardous materials is most common in surgical suites, clinical procedural settings, and intensive, and post-operative care units where body fluids, including blood and irrigation fluids, are removed from the patient during the procedure. Medical personnel may be exposed to these potentially serious biohazards during the course of their job performance, via direct contact of blood materials, or more indirectly, via splash and spray.
Current methods for the removal, containment, and disposal of high volume wastes containing these potentially hazardous materials pose the greatest risk of exposure to the healthcare team. For example, during the course of surgical and certain medical procedures, these fluids are continuously removed from the procedure site, via one or more end effectors operably coupled to wall suction via tubing. These fluids are suctioned into an end collection device and moved through tubing to a collection canister. In order to prevent them from entering a wall suction system where they would contaminate said system, the fluids are collected and stored, for the duration of the procedure, in large canisters (typically 1,500-3,000 cc capacity) positioned adjacent to the site of the procedure. These canisters are necessary to protect the integrity of the wall suction source and to assist the healthcare team in determining the hemostasis of the patient. Such canisters have graduated markings on them, allowing the healthcare team to make estimates of the volume of fluid loss from the patient during and following the procedure. The canisters are usually made of clear plastic material or glass and provide the healthcare team with qualitative, visual assessment by viewing the color of the fluids within the canister as an indicator of actual blood loss. The fluid contents are retained in the canisters adjacent to the procedure site until said procedure is completed, at which time post-operative assessment and documentation of fluids lost by the patient can be assessed.
During a surgical procedure, it is routine for the surgical team to estimate fluid loss using the measurement calibrations on the canister to roughly quantify fluid volumes removed from the site. These volumes are compared to known quantities of fluid introduced, e.g. sterile saline, which provides irrigation of tissue for enhanced visualization and prevention of tissue desiccation. After the procedure is completed, the removed fluids are measured and a calculation of total blood loss is determined. This is done to ensure no excess fluids of any type remain within the body cavity or that excessive blood loss has not occurred, both being circumstances that may place the patient at an increased post-operative risk.
Once total blood loss has been calculated, healthcare personnel must dispose of the fluids remaining in the canister(s). In one current method, this is done by removing the canister from the procedure site and transporting it to a disposal site within the facility. There, the top of the canister is manually opened and the contents are poured into a specially designated sink called a Hopper. The liquid waste is thus drained directly to the sanitary sewer, a process that exposes the healthcare worker to the most risk for direct contact or splash exposure. Once emptied, the canister(s) is placed in large, red pigmented, trash bags and disposed of as biohazardous waste—a process commonly referred to as “Red-Bagging.” Alternatively, the canister(s) is opened in the operating room and a gel forming chemical powder is poured into each canister rendering the material gelatinous. These gelled canisters are then Red-Bagged and removed to a biohazardous holding area for disposal. In larger facilities, the canisters, whether pre-treated with gel or not, are often removed on large carts and transported to a separate biohazardous handling area where they are processed and prepared for disposal. Red-Bagged materials are disposed of separately from other medical and non-medical waste by companies specializing in that method of disposal.
Although these protection and disposal techniques are helpful and provide some measure of improvement over earlier methods, they fall short of providing adequate protection for healthcare personnel assigned to disposal of biohazardous waste. A major spill of fluid from said canister(s), whether by direct contact as a result of leakage or breakage, splash associated with the opening of the canister lid to add gel, while pouring liquid contents into the Hopper, or during the disposal process itself is cause for concern. Acute exposure to blood components is one of the most serious risks any healthcare worker faces in the performance of his or her job. Once a spill occurs, the entire area around the spill must be cleaned and disinfected and the exposed worker faces an uncertain future with regard to potential infection from bloodborne pathogens. These pathogens include, but are not limited to, HIV, HPV, and other infectious agents.
The present invention is well suited for use in the medical field, particularly in surgery, clinical settings, intensive and post-operative care units, whether such procedures and care are being carried out in an operating room or other clinical locations. It provides for the removal and disposal of certain fluids and liquids which are associated with medical procedures and protocols, and provides for assessing or measuring the quantity of and other essential characteristics of such liquids, e.g. saline solution, blood, plasma, ascites and the like, produced or used during said procedures or protocols.
In addition, the present invention is well suited for use in many other markets, including but not limited to, veterinary medicine, research facilities, manufacturing and industrial applications, coroner and mortuary procedures, and food processing applications.